DCT
2:25-cv-02893
Aurinia Pharma Inc v. Zydus Pharma USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Aurinia Pharmaceuticals Inc. (Canada)
- Defendant: Zydus Pharmaceuticals (USA) Inc. (New Jersey); Zydus Lifesciences Limited (India)
- Plaintiff’s Counsel: Gibbons P.C.
- Case Identification: 2:25-cv-02893, D.N.J., 04/21/2025
- Venue Allegations: Venue is alleged to be proper as to Zydus Pharmaceuticals (USA) Inc. based on its maintenance of a regular and established place of business in the district. Venue is alleged against Zydus Lifesciences Limited on the basis that it is a foreign corporation, making venue proper in any judicial district.
- Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's LUPKYNIS® (voclosporin) drug product constitutes an act of infringement of two patents covering methods for treating lupus nephritis.
- Technical Context: The technology concerns a specific pharmacodynamic dosing protocol for voclosporin, an immunosuppressant drug used to treat lupus nephritis, a serious autoimmune disease that causes kidney inflammation.
- Key Procedural History: This is a Hatch-Waxman action initiated in response to a Paragraph IV certification notice letter from Defendants dated March 7, 2025. The complaint was filed within the 45-day statutory window, which triggers an automatic 30-month stay of FDA approval for the Defendants' generic product.
Case Timeline
| Date | Event |
|---|---|
| 2017-05-12 | Earliest Priority Date for '036 & '991 Patents |
| 2019-05-14 | '036 Patent Issued |
| 2021-01-22 | FDA Approved NDA for LUPKYNIS® |
| 2023-04-11 | '991 Patent Issued |
| 2025-03-07 | Zydus Sent Paragraph IV Notice Letter to Aurinia |
| 2025-04-21 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,286,036 - Protocol for 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 shown limited success, with low rates of complete remission ('036 Patent, col. 4:38-44). Furthermore, it notes that a known side effect of treatment with the drug voclosporin is an "unwanted decrease in the estimated glomerular filtration rate (eGFR)," a key measure of kidney function ('036 Patent, col. 4:62-64).
- The Patented Solution: The patent discloses a "pharmacodynamic" method for treating a proteinuric kidney disease like LN. The method involves administering voclosporin, monitoring the patient's eGFR, and then adjusting the dosage—specifically, reducing or stopping the drug—if the eGFR decreases by a specified target percentage to below a predetermined value ('036 Patent, col. 5:1-19). This protocol, illustrated in the clinical trial design of Figure 1, is designed to maximize the drug's therapeutic effect while mitigating the risk of kidney damage ('036 Patent, col. 4:65-67).
- Technical Importance: The invention provides a personalized dosing regimen that allows clinicians to use a potent therapeutic agent while actively managing a significant, known side effect, potentially improving the overall safety and efficacy profile of the treatment.
Key Claims at a Glance
- The complaint asserts at least one claim of the '036 patent (Compl. ¶45). Independent claim 1 is central to the patent.
- Independent Claim 1 recites a pharmacodynamic method for treating a proteinuric kidney disease over at least 24 weeks, which includes the steps of:
- Administering a predetermined daily dosage of voclosporin.
- Assessing the patient's eGFR at a first and second time point.
- Reducing or stopping the voclosporin dosage if the eGFR decreases by more than a "target %" (in the range of 20-45%) to below a predetermined value (in the range of 50-90 ml/min/1.73 m²).
- Continuing the same dosage if the eGFR decreases by less than the target percentage.
- The complaint does not specify if it asserts dependent claims.
U.S. Patent No. 11,622,991 - Protocol for Treatment of Lupus Nephritis, Issued April 11, 2023
The Invention Explained
- Problem Addressed: The patent addresses the same challenges as its parent '036 patent: the need for more effective treatments for LN and the management of voclosporin-induced side effects like decreased eGFR ('991 Patent, col. 2:25-34; col. 3:15-18).
- The Patented Solution: The '991 patent discloses a more specific method for treating LN. It requires selecting a patient with LN and a baseline eGFR, then administering a specific starting dose of voclosporin (23.7 mg twice daily) in combination with mycophenolate mofetil (MMF) and corticosteroids ('991 Patent, col. 28:58-65). The core of the method is a precise rule for dose reduction: if the patient's eGFR decreases by a specific amount (>20% to <30%), the voclosporin dose is reduced to a specific lower level (15.8 mg or 7.9 mg twice daily) ('991 Patent, col. 29:1-11). Figure 2 provides clinical data showing remission rates for this type of protocol ('991 Patent, Fig. 2).
- Technical Importance: This patent refines the general pharmacodynamic approach of the '036 patent into a concrete, clinically-tested treatment protocol with specific starting doses, co-therapies, and dose-adjustment criteria.
Key Claims at a Glance
- The complaint asserts at least one claim of the '991 patent (Compl. ¶58). Independent claims 1 and 14 are central.
- Independent Claim 1 recites a method of treating LN, which includes the steps of:
- Selecting a patient with LN and determining their eGFR at a first time point.
- Administering a starting dose of 23.7 mg voclosporin twice daily (BID), along with MMF and corticosteroids.
- Assessing the patient's eGFR at a second time point.
- Administering a reduced dose of 15.8 mg or 7.9 mg BID voclosporin if the eGFR decreases in the range of >20% to <30% to a value below 60 ml/min/1.73 m².
- Independent Claim 14 is similar to claim 1 but adds a final efficacy requirement: that the administration of the reduced dose "achieves a urine protein creatinine ratio (UPCR) of <0.5 mg/mg."
- The complaint does not specify if it asserts dependent claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are Zydus’s "generic voclosporin products" for which Zydus seeks FDA approval via ANDA No. 220141 (Compl. ¶1).
Functionality and Market Context
- The complaint alleges that Zydus's generic voclosporin products are "the same, or substantially the same, as Aurinia's LUPKYNIS®" (Compl. ¶34). The infringement theory is not based on the composition of the drug itself, but on its intended use. The complaint alleges that Zydus will induce infringement because the proposed package insert for its generic product will instruct physicians and patients to administer the drug according to a method that meets the limitations of the asserted patent claims (Compl. ¶¶47-48, 60-61). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not provide a claim chart or specific details of the infringing activity, which is common in initial ANDA complaints. The infringement theory relies on the allegation that Zydus's proposed product label will instruct the patented methods.
'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... | The proposed package insert for Zydus's generic voclosporin will allegedly instruct healthcare professionals to treat patients with lupus nephritis by administering the drug (Compl. ¶48). | ¶48 | col. 5:1-5 |
| (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 package insert will allegedly instruct healthcare professionals to monitor patient eGFR during treatment, which constitutes an assessment at different time points (Compl. ¶48). | ¶48 | col. 5:6-10 |
| (b) (i) if the eGFR of said subject decreases by more than a target %... to below a predetermined value... reducing the daily dosage... or stopping the administering of voclosporin to said subject; | The proposed package insert will allegedly instruct healthcare professionals to reduce or stop the dosage of Zydus's generic voclosporin if the patient's eGFR decreases in a manner that meets the criteria of the claim, thereby inducing infringement of the claimed dose-adjustment step (Compl. ¶¶47-48). | ¶47, ¶48 | col. 5:11-16 |
| (ii) if the eGFR of said subject decreases by less than said target %... continuing administering the same predetermined daily dosage of voclosporin to said subject. | The proposed package insert will allegedly instruct or imply that the same dosage should be continued if the patient's eGFR does not decrease significantly, thereby inducing infringement of this limitation (Compl. ¶¶47-48). | ¶47, ¶48 | col. 5:17-19 |
'991 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| b) administering to the subject voclosporin, mycophenolate mofetil (MMF), and corticosteroids, wherein the administering comprises administering the voclosporin at a starting dose of 23.7 mg administered orally twice daily (BID); | The proposed package insert for Zydus's generic voclosporin will allegedly instruct co-administration with MMF and corticosteroids and specify a starting dose of 23.7 mg BID, thereby mirroring the branded product's label and infringing this claim element (Compl. ¶61). | ¶61 | col. 28:60-65 |
| d) administering to the subject a reduced dose of 15.8 mg BID or 7.9 mg BID voclosporin... if, between the first and the second time points, the subject's eGFR decreases in the range of >20% to <30%... to below 60 ml/min/1.73 m². | The proposed package insert will allegedly instruct physicians to reduce the dose to 15.8 mg BID or 7.9 mg BID if the patient's eGFR decreases according to the specific quantitative criteria recited in the claim, thereby inducing infringement of the dose-reduction step (Compl. ¶61). | ¶61 | col. 29:1-11 |
- Identified Points of Contention:
- Evidentiary Question: The central issue will be the precise content of the proposed package insert for Zydus's generic product. The case will turn on whether that label language instructs or encourages physicians to perform each limitation of the asserted claims.
- Scope Question: For both patents, a key question is whether the label's instructions for monitoring eGFR and adjusting dosage will be specific enough to map directly onto the quantitative thresholds defined in the claims (e.g., the ">20% to <30%" range in claim 1 of the '991 patent), or if the label will provide more general guidance that may not meet the claim limitations.
V. Key Claim Terms for Construction
- The Term: "pharmacodynamic method" ('036 Patent, Claim 1 Preamble)
- Context and Importance: This preamble term may be argued by Zydus to be a substantive limitation on the claim's scope. The dispute would center on whether the set of actions described in a product label constitutes a "pharmacodynamic method," or if that term requires a more active, real-time clinical judgment that a static label cannot instruct.
- Intrinsic Evidence for a Broader Interpretation: The specification refers to the invention as providing a "pharmacodynamic dosing schedule based on individual patient responses," suggesting the term relates to any method that adjusts dosing based on patient-specific physiological markers ('036 Patent, col. 4:20-23).
- Intrinsic Evidence for a Narrower Interpretation: The body of claim 1 recites a highly specific rule-based system for dose adjustment. A defendant could argue that the term "pharmacodynamic method" is defined and limited by this specific set of rules, rather than encompassing any patient-responsive dosing.
- The Term: "assessing the estimated Glomerular Filtration Rate (eGFR)" ('036 Patent, Claim 1; '991 Patent, Claim 1)
- Context and Importance: Practitioners may focus on this term because the infringement allegation is based on a label instruction. A dispute may arise over whether a doctor who simply reviews a lab report is "assessing" the eGFR in the manner required by the claim, and whether a label "instructs" this specific mental step.
- Intrinsic Evidence for a Broader Interpretation: The patent uses the term in the context of a clinical protocol where monitoring patient data is standard. The specification refers to "assessments of parameters" and "evaluating" the subject, suggesting a routine review of clinical data ('036 Patent, col. 4:31-33).
- Intrinsic Evidence for a Narrower Interpretation: A defendant could argue that "assessing" implies more than just receiving data, but requires a specific analytical or diagnostic conclusion that a label cannot instruct a physician to make. The patent links the assessment directly to a decision to alter treatment, suggesting it is an active, rather than passive, step ('036 Patent, col. 5:6-19).
VI. Other Allegations
- Indirect Infringement: The complaint's theory of liability is centered on induced infringement under 35 U.S.C. § 271(b). It alleges that Zydus, with knowledge of the patents, will induce infringement by "at least healthcare professionals" through the instructions contained in its proposed package insert (Compl. ¶¶47-48, 60-61). The complaint also alleges contributory infringement, stating the generic products are a material part of the invention and not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶¶49-50, 62-63).
- Willful Infringement: The complaint does not use the word "willful," but it lays the foundation for such a claim. It alleges that Zydus has had "actual knowledge" of the '036 and '991 patents since at least the date of its Notice Letter on March 7, 2025 (Compl. ¶¶43, 56).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of instructional precision: will the final, FDA-approved package insert for Zydus’s generic voclosporin contain instructions that map directly onto each specific, quantitative limitation of the asserted method claims, including the starting dose, eGFR monitoring thresholds, and dose reduction amounts?
- A key legal question will be one of infringement by label: assuming the Zydus label mirrors the existing LUPKYNIS® label, does that label's language, as a matter of law, actively "instruct" or "encourage" a physician to perform the patented method, or does it merely provide information that leaves the physician with non-infringing treatment options, thereby failing to meet the legal standard for inducement?